A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Monday, 1 August 2016

New referral to the CJEU

In Merck Shark & Dohme v Comptroller-General of Patents [2016] EWHC 1896 (an appeal to BL O/117/16), Mr Justice Arnold has referred the following questions to the CJEU for a preliminary ruling:

(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?

(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

This case arose because Merck Sharp & Dohme filed an SPC application one day before patent expiry but only had the "End of Procedure Communication" but not a marketing authorisation.